Soletra for Deep Brain Stimulation

Implant Procedure

Placement of the Medtronic DBS™ leads

1. A stereotactic head frame is attached to the patient's skull under local anesthetic to keep the patient comfortable.
2. The patient is then imaged with the frame on, and the target(s) are localized using targeting software.

• Sophisticated imaging and software enables precise targeting for optimal outcomes and minimal risk

3. For lead placement, a nickel-sized (14 mm) burr hole is then made in the patient's skull.
4. A burr-hole ring is affixed to each opening.
5. Prior to lead placement, microelectrode recording (MER) may be used to provide an additional level of target verification.
6. Stereotactic frame guidance and techniques are then used to place the lead to the targeted area.
7. With the patient awake, a test stimulation is performed to confirm good therapeutic benefit (for example, reduced rigidity and/or tremor) with minimal or no side effects.
8. Once lead placement is confirmed, the lead is secured by closing the burr-hole cover or Stimloc protective cap.

Targeted sites for Deep Brain Stimulation:

Subthalamic Nucleus

Globus Pallidus

Targeted sites for OCD:

Anterior limb of the internal capsule (AIC) more specifically, the ventral capsule/ventral striatum (VC/VS)

Placement of the neurostimulator

This step may be done either on an inpatient or outpatient basis, and may or may not be done at the same time as the lead placement. Patients typically receive general anesthesia during this procedure.

• A small incision is made in the subclavicular area to create a pocket and the neurostimulator is placed in the pocket.
• The lead is then connected to the extension, which is tunneled under the scalp, the skin of the neck, and down to the pocket. For bilateral applications, these steps are repeated for the other side.

Inpatient Stay

A deep brain stimulation patient typically is discharged the day following the placement of the leads. If the neurostimulator hasn't been placed along with the leads, the neurostimulator is usually implanted on an outpatient basis. In this case, the patient is discharged the same day.

Post-Surgical Follow-Up

Movement Disorders

DBS patients return to the surgeon to have their sutures removed on a date determined by the clinician. Two to 4 weeks after surgery, a patient can go in for the first office visit to have the neurostimulator turned on and programmed.

Patients often experience symptom relief after the surgery without stimulation. This< "microlesion effect" typically wears off in the days following surgery. Some clinicians consider this effect the result of edema around the implanted lead in the brain. When the edema has subsided, the patient's stimulation can be adjusted to maximize therapeutic benefit and minimize side effects.

Some clinicians ask patients to stop taking some or all of their medications for 12 to 24 hours before programming to best observe the effects of stimulation. Patients with severe symptoms may find that reducing or stopping their medications is too uncomfortable. For those patients, the amount of medication they take may be reduced but not eliminated during programming. Patients are typically given a dose of medication following programming to ensure that stimulation effects are stable under medication.

The patient will typically return to his or her clinician frequently in the first few months following surgery to optimize stimulation and titrate medications. Patients then resume a normal schedule of visits with their managing physician to monitor the status of their disease and adjust stimulation as necessary.

Obsessive-Compulsive Disorder*

DBS patients return to the surgeon to have their sutures removed on a date determined by the clinician. Two to 4 weeks after surgery, a patient can go in for the first office visit to have the neurostimulator turned on and programmed.

The patient will typically return to his or her clinician frequently in the first few months following surgery to optimize stimulation and titrate medications. Patients then resume a normal schedule of visits with their managing physician to monitor the status of their disease and adjust stimulation as necessary.

* Humanitarian Device: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

Device Replacement

The neurostimulator battery is designed to last from 2 to 5 years in patients with movement disorders. Depending on the parameters selected, the battery may require replacement in less than 2 years. The neurostimulator battery may last 6-16 months for patients with OCD; using typical stimulation parameters.

Replacement of the neurostimulator is typically done on an outpatient basis. No intracranial procedure is typically necessary.